JETTBarrierIsolatorURSWord文件下载.docx
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JETTBarrierIsolatorURSWord文件下载.docx
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MCasey
Validationreview
C1
11/20/02
MRivera
FormatReview
C2
11/26/02
Finalreviewofcontentandformatbyauthor
ApprovedforInitialRelease
TableofContents
1.0Introduction5
2.0Overview5
3.0OperationalRequirements6
3.1Capacity6
3.2ProcessRequirements6
3.3ProcessControl6
3.4Functions7
3.5DataandSecurity9
3.6Environment11
4.0Constraints14
4.1MilestonesandTimelines14
4.2EquipmentConstraints15
4.3CompatibilityandSupport15
4.4Availability17
4.5ProceduralConstraints17
4.6Maintenance19
5.0Life-Cycle19
5.1Development19
5.2Testing19
5.3Delivery20
5.4Support21
6.0Glossary22
7.0References23
8.0Approval24
ProjectNo.:
InserttheuniqueprojectnumberassociatedwiththisparticularURS.
DocumentNo.:
InserttheDocumentIdentificationNumberandRevision.
DocumentDescription:
Insertdescriptionofdocument,e.g.PURESTEAMGENERATOR,JETTExampleUserRequirementsSpecification.
Introduction
Note:
Insertyourowndescriptionandintroduction.Youmaywishtoincludeyourownrequirementsandspecificstoallowtheinexperiencedreader,contractors,andsuppliersadequateexplanationtounderstandthescopeoftheequipment.
Describewhoproducedthedocument,underwhatauthority,andforwhatpurpose.
Describethecontractualstatusofthedocument.Includeorreferenceasanattachmentthe“legal”paragraphthatcommunicatespurchasingtermsandconditionsinthissection.
Describetherelationshipofthisdocumenttootherdocuments.ThisisimportantforequipmentthatispartofanintegratedprocessorlineandwillhelptheSuppliertounderstandandaskquestionsthatmayotherwisebeoverlooked.
RefertotheEquipmentValidationPlanthatoutlinestheSupplier’sresponsibilitiesisattached.
Removeanyoptionsthatarenotapplicableforthisproject,ifotheruseswillapplylisteachseparately.
Thisistobeutilizedasaguidefortheusertoanswerthemajorityofquestionsinvolvedinspecifyingthe“what”fortheequipment.Addendumsmaybeusedtoroundouttherequirements.
Overview
TheBarrierIsolatorandHVACSystemprovidesamechanicalseparationbetweenthecontrolledroomenvironment,andtheinteriorenvironmentinwhichthepharmaceuticalproductisprocessed.Thebarrierisolatorismanufacturedinsuchamannerthatthematerialsareresistanttocorrosion,donotallowpoolingofthecleaningmaterials,andallowaccesstotheinteriorasrequiredbytheequipmentandproducts.Theenvironmentinsidethebarrierisolatoriscontrolledinamannertoallowthepharmaceuticalproducttobeprocessedinaccordancewiththepurposeandproductrequirements.
USE
Theequipmentshallbeusedprimarilyfor:
∙ContinuousProduction
∙BatchProduction
∙Other
EQUIPMENTCLASSIFICATION
Forexample:
Forprovidinganasepticenvironmentfor:
∙Liquidfillingofvialswithstoppers
∙Powderfillingofvialswithstoppers
∙Liquidfillingofampouleswithflame-off
∙Liquidfillingofcartridgeswithplugs
∙Liquidfillingofsyringes
∙Other(define)
InsertyourEquipmentClassificationshereasrequiredusingtheaboveexampleasaguide.
CLEANINGREQUIREMENTS
∙Wipedown
∙ManualWashdown
∙Clean-In-Place(CIP)
∙SpecialRequirements:
–PeraceticAcid
–EthyleneOxide
–ChlorineDioxide
–VaporizedHydrogenPeroxide
–Others
LANGUAGEREQUIREMENTS
∙English
∙Other(Specify):
____________________
∙Bilingual?
Yes/No
OperationalRequirements
PERFORMANCEREQUIREMENTS
Capacity
Addcapacitiesanddetailsconcerningequipmentcapacityhere.Identifythetypeanddimensionsoftheequipmentthatwillfitinsideofthebarrier.
FUNCTIONS
TheBarrierIsolatorandHVACSystemisdividedintotwomainportions:
Thebarrierisolator,andtheHVACsystem.
BarrierIsolatorOperation
Thebarrierisolatorisanenclosurethatprovidesisolationbetweentheoperator/outsideenvironmentandtheinteriorofthebarrierwherethepharmaceuticalprocessingisdone.Thebarrierisolatorprovidesthefollowingfunctions:
∙Isolationbetweentheoperatorandtheprocess
∙SafetyBarriertoseparatetheoperatorfromequipmenthazards
∙Anon-corrosive,drainable,andeasilycleanedenclosure.
∙Doorstoprovideaccesstotheequipmentduringcleaningandchangeover
∙Gloveportstoallowaccesstomachineryandproductduringproduction
∙Transferportstointroducecommoditiesandequipmenttotheenvironment
∙Infeedopeningtointroducecommoditiestothesystem.
∙Exitopeningtoallowfinishedcommoditiestoexitthesystem.
BarrierIsolatorDesign
ThebarrierisolatordesignwillmeetcurrentGMPforasepticproductmanufacture,alongwithwashdownandsanitizationrequirements.
Allinteriorcornerswillhaveaminimumof__0.5”_radius.
Drainpanswillhaveaminimumof__0.5”__slopeper12”ofrun.
Horizontalsurfaceswillbeminimizedtoresistpooling.Poolingofmorethan__5ml__ofliquidisnotallowed.Pooledliquidmustnotbemorethan__2mm__deep
Drainpansshallterminateintankbottomdrainvalveswithmaterialsandfinishequivalenttotherestofthebarrierisolatorinterior.
Airdistributionfromtheplenumwilluse__dualperforatedplates__.
Theairdistributionsystemwillberemovableforcleaning.
Safetyoftheoperatorfromthemachineryorprocesseswithinthebarrierisolatormustbeensured.
Alldoorswillhavedual-redundantsafetyswitchesthatwillimmediatelystopallmachineryorprocesseswhenthedoorisopened.
Gloveportswillbeguardedwithlightcurtainstoimmediatelystopmachinery.
Allmovingmachineryexternaltothebarrierisolatorwillbefullyguardedandalarmed.
Allhightemperaturecomponentsexternaltothebarrierisolatorwillbefullyguardedandalarmed.
MaterialsandFinishoftheBarrierIsolatorwillmeetcurrentGMP’s.
1.Wallthicknessofthebarrierisolatorwillbeaminimumof__7gauge_StainlessSteel
2.Interiorsurfacesofthebarrierisolatorwillbemanufacturedfrom__316L________StainlessSteel.
3.Exteriorsurfacesofthebarrierisolatorandductworkwillbemanufacturedfrom__304or316L___StainlessSteel.
4.Interiorfinishofthebarrierisolatorwillbeof_______40_micro-inchRafinishmaximum.
5.Exteriorfinishofthebarrierisolatorwillbeof______120_micro-inchRafinishmaximum.
6.Allinteriorsurfaceswillbeelectro-polishedredundant?
Howelsedoyouget#4and#5?
.
7.Allweldswillbegroundandpolishedtotheabovefinishrequirements.
8.Airplenumsmustmeetthesamematerialsandfinishrequirementsasthebarrierisolator.
9.Thecompletedinteriorofthebarrierisolatorwillbepassivatedpriortoshipmenttothesite.
10.ComponentsattachedtotheexteriorofthebarrierisolatormustmeetcurrentGMP’sandbefinishedtoresistcorrosion.
DoorsandWindowsinthebarrierisolatorallowvisibilityandaccesstotheinterior.
1.Thewindowmaterialismanufacturedfrom__temperedsafetyglassorpolycarbonate__.
2.Thewindowsealingmaterialisextrudedfrom__siliconerubber__.
3.Windowsealsmustbedesignedtopreventpooling.
4.Doorsmusthingeopentoallowaccesstotheinterior.
5.Doorsmustberemovablewithouttools.
MouseholeOpening(s)areprovidedattheexitpointtoallowtheexitofgoodvialsandofrejectvials.
1.MouseholecoversaremanufacturedtothesamerequirementsasthebarrierIsolator.
2.Mouseholecoverpresenceistobesensedandalarmed.
Gloveportsareprovidedinthebarrierisolatortoallowoperatoraccesstotheinteriorwithoutcompromisingsterility.
1.Glovesmustbereplaceable.
2.Glovesmustbesanitizedwithoutabsorbingsterilant.
3.Gloveswillbemadefrom__fabricreinforcedPVC__.
4.Gloveswillbelocatedtoaccesscommoninterventionpoints.
5.Gloveswillbepositionedtoallowaccessbyoperatorswithinthenormalrangeofphysicalsizes.
TransferPortswillbeprovidedtoallowcomponentandproductentryintotheinteriorofthebarrierisolatorwithoutcompromisingsterility.
1.Transferportswillbelocatedatthefollowinglocations,andareofthefollowingsizes:
Location#1:
___upstreamoffiller____350mm__
Location#2:
___atstopperentry______270mm__
Location#3:
___atoutfeed__________270mm__
Location#4:
___N/A______________________
2.Transferportmanufactureis_____________________
3.Transferportsanitizationprocessis_______________
Commodity/ProductInfeedtotheinteriorofthebarrierisolatorwillbeprovidedinthedesign.
1.Vialsenterthebarrierisolatorfroma__depyrogenationtunnel__.
2.Productentersthebarrierisolatorthrougha__bulkheadfitting__.
3.Stoppersenterthebarrierisolatorthrough__transferport#2____.
4.MiscellaneousDevicessuchas:
__tools,SMAstands,hangers,platforms,instrumentation,testports,etc.___
ProductExitfromtheinteriorofthebarrierisolatorwillbeprovidedinthedesign.
5.Vialpath#1transfersvialstoa__flatbeltconveyor__.
6.Vialpath#2transfersvialstoa__22”transferdisk__.
7.Drainsinthebottomofthebarrierisolatorareprovidedat__7__pointstoallowforliquidstoberemovedduringchangeoverandsanitization.
8.Drainsmustbeclosedduringproduction.
HVACSystemOperation
TheHVACsystemcontrolstheenvironmentinsidetheisolator,andprovidesthefollowingfunctions:
∙Pressuredifferentialbetweentheinteriorandexterioroftheisolator
∙Temperaturecontrolofthei
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